Camber Spine Gains FDA 510(k) for SPIRA-P and SPIRA-T Technologies

By Julie A. Vetalice

Camber Spine Gains FDA 510(k) for SPIRA-P and SPIRA-T Technologies

Camber Spine received FDA 510(k) clearance to market its SPIRA-P Posterior Lumbar Spacer and SPIRA-T Oblique Posterior Lumbar Spacer technologies.

Part of the 3D-printed SPIRA® product platform, the SPIRA-P Posterior Lumbar Spacer can be utilized to accommodate PLIF or TLIF and features a patented open architecture design for optimal endplate load distribution. Its surface allows for cell adhesion and bone cell proliferation while its interconnected porosity design mimics bone.

The SPIRA-T Oblique Posterior Lumbar Spacer features the same qualities, but is designed specifically to accommodate traditional or “insert and rotate” TLIF procedures. Its shape is angled for a 25° oblique insertion technique to optimize lordosis.

As with all products within Camber’s SPIRA technology platform, SPIRA-P and SPIRA-T include strategically placed and optimal sized openings for graft packing. It also decreases the risk of subsidence due to the design’s “snowshoe effect” and provides good visibility for fusion.

Camber Co-Founder and CEO, Daniel Pontecorvo, said, “SPIRA Posterior Lumbar Spacers have different shapes and designs to accommodate a broader array of posterior and transforaminal approaches and techniques. These new products are also significant in that they are our first SPIRA implants available for the TLIF market – the number one interbody market in the US today. To further expand upon this, we look forward to launching an articulating, arched TLIF SPIRA cage product in early 2022.”

Source: Camber Spine

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory